FDA.reportPublic FDA data

HANAROSTENT® LowAxTM Colon/Rectum(NNN)

Primary DI
08806367080615
Brand
HANAROSTENT® LowAxTM Colon/Rectum(NNN)
Company
M.I.Tech Co., Ltd.
Model
CNJF-20-090-230
Device description
Un-covered self-expanding nitinol colon stent
Published
2019-02-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQRStent, Colonic, Metallic, Expandable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQRStent, Colonic, Metallic, ExpandableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183616000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183616000HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd.2019-01-10MQR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806367080615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806367080615088063670806158806367080615

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal colonic stentA sterile non-bioabsorbable tubular device intended to be implanted in the lumen of the colon for the palliative treatment of colonic strictures caused by malignant neoplasms typically in the descending or sigmoid colon, or rectum. It is typically inserted and advanced to the site of implantation with a dedicated catheter, or other instrument, where it self-expands upon release. It is made of metal [e.g., stainless steel or metal alloy such as nickel-titanium alloy (Nitinol)] in a tubular mesh configuration, and is available in various sizes. It will typically be used to relieve large bowel obstruction prior to colectomy, or in patients having high operative risk and/or advanced disease.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2300Millimeter
Stent Diameter20Millimeter
Stent Length90Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+821042945040skim@mitechglobal.com

Regulatory Flags#

DUNS number
688454359
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806367080516HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-20-060-1402019-02-18
08806367080547HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-20-090-1402019-02-18
08806367080578HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-20-120-1402019-02-18
08806367080585HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-20-060-2302019-02-18
08806367080646HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-20-120-2302019-02-18
08806367080653HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-22-060-1402019-02-18
08806367080684HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-22-090-1402019-02-18
08806367080714HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-22-120-1402019-02-18
08806367080721HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-22-060-2302019-02-18
08806367080752HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-22-090-2302019-02-18
08806367080783HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-22-120-2302019-02-18
08806367080790HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-25-060-1402019-03-11
08806367080820HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-25-090-1402019-03-11
08806367080851HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-25-120-1402019-03-11
08806367080868HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-25-060-2302019-03-11
08806367080899HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-25-090-2302019-03-11
08806367080929HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-25-120-2302019-03-11
08806367081070HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)DNJF-20-060-1402019-02-18
08806367081100HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)DNJF-20-090-1402019-02-18
08806367081131HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)DNJF-20-120-1402019-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536219681Small VBR (ADD)Ulrich GmbH & Co. KGMQR2026-03-03
04052536219605ADDUlrich GmbH & Co. KGMQR2025-08-25
04052536009510ADDUlrich GmbH & Co. KGMQR2024-10-29
08809909414367Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414374Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414381Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414398Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414404Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414411Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414428Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414435Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08714729902584WallFlex™ ColonicBOSTON SCIENTIFIC CORPORATIONMQR2020-05-26
08714729902591WallFlex™ ColonicBOSTON SCIENTIFIC CORPORATIONMQR2020-05-26
08714729902607WallFlex™ ColonicBOSTON SCIENTIFIC CORPORATIONMQR2020-05-26
08806367080790HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080820HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080851HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080868HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080899HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080929HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080516HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080547HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080578HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080585HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080646HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080653HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080684HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080714HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080721HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080752HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18